IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania (Ferinject)

April 22, 2017 updated by: Ifakara Health Institute

Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania

Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objectives of the study are as follows:

Primary objective:

To assess the superiority in terms of effectiveness of iv iron substitution with ferric carboxymaltose versus per oral iron substitution in women with iron deficient anemia at delivery in Tanzania.

Secondary objectives

  • To evaluate safety and feasibility of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
  • To evaluate acceptance of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
  • To evaluate wellbeing of women receiving intravenous ferric carboxymaltose compared to women receiving per oral iron substitution
  • To evaluate the sensitivity of diagnosis of iron deficiency by measuring hemoglobin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC) only, compared to the diagnosis by measuring iron metabolism parameters in a resource limited country

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Bagamoyo, Tanzania, 74
        • Ifakara Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women close to delivery
  • Screening will be performed using the HemoCue System. In case of anemia, defined by Hg <110 g/l, a venous puncture will be performed and the blood analyzed on a 5 population analyzer with erythrocyte indices and Reticulocyte indices and ferritin determined. Then If the anemia defined as Hg <110 g/l is confirmed and the if ferritin is below 50 ng/ml, the patient will be included in the present study
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • Patient must give written informed consent before registration

Exclusion Criteria:

  • Active malaria; patients will be tested for malaria by Rapid Diagnostic Test and microscopy and if positive treated. Patient with treated malaria can be included
  • Helminthic infection; patients will be tested for helminthic infections by a stool ova and parasite exam and if positive treated by single oral dose of 400 mg albendazole. Treated patients can be included.
  • HIV positivity. Patients will be tested and if positive they will be referred to the Care and Treatment Clinic at Bagamoyo District Hospital and excluded from the study.
  • Known hemoglobinopathy
  • C-Reactive protein (CRP) >20
  • Patients with chronic fever
  • Psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
  • Concurrent treatment with other experimental drugs or treatment in another clinical trial within 30 days prior to trial entry
  • Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial
  • Known allergy or hypersensitivity to study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV ferric carboxymaltose
IV Ferric carboxymaltose is given at a dose calculated according to the severity of anemia and patients weight. The maximal weekly dose is 1000mg. If total dose exceeds 1000mg the dose is split in 1-3 infusions with one infusion per week.
Drug: Ferric carboxymaltose
Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia
Other Names:
  • Ferinject
Active Comparator: Ferrous sulphate 60mg+Folic acid 0.25mg
Three dried ferrous sulphate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia.
Drug: Ferrous sulfate + folic acid
Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia
Other Names:
  • Fefo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm
Time Frame: 6 weeks
The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best response (Hemoglobin) in grams per decilitre (g/dl)
Time Frame: up to 1 year
Is the highest hemoglobin value or maximal hemoglobin increase after start of study medication
up to 1 year
Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm
Time Frame: 6 weeks
The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment in nanograms per milliltre(ng/mL)
6 weeks
Best response (Ferritin) in nanograms per milliltre (ng/mL)
Time Frame: up to 1 year

Is the highest ferritin value or maximal ferritin increase after start of study medication.

The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment
up to 1 year
Time to response (Hemoglobin) in weeks
Time Frame: up to 1 year
Is the time interval between the date of start of study medication until the date of reaching maximal hemoglobin value
up to 1 year
Time to response (Ferritin) in weeks
Time Frame: up to 1 year
Is the time interval between the date of start of study medication until the date of reaching maximal ferritin value
up to 1 year
Response duration (Hemoglobin) in weeks
Time Frame: up to 1 year
Is the time from the date when the highest hemoglobin value is reached until the date of decrease to Hb<11.5 g/dl or a decrease of more than 1 g/dl
up to 1 year
Response duration (Ferritin) in weeks
Time Frame: up to 1 year
Is the time from the date when the highest ferritin value is reached until the date of decrease to ferritin<50 ng/ml
up to 1 year
Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution
Time Frame: up to 1 year
Number of participants with adverse events either clinical events or abnormal laboratory values with grading of severity reported according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4
up to 1 year
Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count)
Time Frame: up to 1 year
The proportion of women in each trial arm who have completed the trial related treatment either the number of prescribed infusions of ferric carboxymaltose or oral tablets of ferrous sulphate and folic acid
up to 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
Time Frame: 1 year
Is the probability that a test (erythrocyte indices) will indicate iron deficiency among participants with the disease as confirmed by iron metabolism parameters (Gold standard). It will be reported as percentage.
1 year
Specificity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania ((parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
Time Frame: 1 year
Is the fraction of those without disease (iron deficiency) confirmed by iron metabolism parameters who will have a negative test (erythrocyte indices) results. It will be reported as percentage.
1 year
Positive predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
Time Frame: 1 year
Is the proportion of participants who truly have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with positive test results(erythrocyte indices). It will be reported as percentage.
1 year
Negative predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
Time Frame: 1 year
Is the proportion of participants who do not have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with negative test results(erythrocyte indices). It will be reported as percentage.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ifakara Health Institute

Collaborators

Swiss Tropical & Public Health Institute

Investigators

  • Principal Investigator: Sandrine Meyer-Monard, PD DrMed, Swiss Tropical & Public Health Institute
  • Study Chair: Salim Abdulla, MD,PhD, Ifakara Health Institute
  • Study Chair: Marcel Tanner, PhD, MPH, Swiss Tropical & Public Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCIDA 001-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iron-Deficiency Anemia

Clinical Trials on Ferric carboxymaltose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe